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Efficacy of praziquantel for treatment of Plasmodium falciparum infection in asymptomatic Gabonese adults: A double-blind placebo-controlled randomized phase IIb clinical trial

J Infect Dis. 2025 Oct 29:jiaf544. doi: 10.1093/infdis/jiaf544. Online ahead of print.

ABSTRACT

BACKGROUND: Schistosomiasis and malaria are major poverty-related parasitic infectious diseases. They are often co-endemic and affect similar target populations. Mass drug administration and intermittent preventive treatment programs are commonly used for their control. From a programmatic perspective the conception of preventive treatment programs targeting both diseases simultaneously would be a great advantage. While there is preliminary evidence that certain anti-malarial drugs exert a clinically important effect on Schistosomes, little is known on whether praziquantel (PZQ), the only licensed drug to treat schistosomiasis, has activity against Plasmodium parasites. Therefore, the CORMA-MAL study was conducted to evaluate anti-malarial activity of PZQ.

METHODS: This double-blinded, randomized, placebo-controlled phase IIb trial was conducted in Lambaréné, Gabon and recruited semi-immune adults with an asymptomatic P. falciparum parasitemia. Participants were randomized (1:1) to receive placebo or 40mg/kg PZQ once daily for three days and followed up for a total of seven days.

RESULTS: 44 participants were recruited. Analytical models indicated a highly significant hourly reduction of microscopically-determined parasitemia in the PZQ arm and a non-significant decreasing trend in the placebo group (regression slopes of log10-transformed parasitemia: β=-0.006 [p<0.001] and β=-0.0013 [p=0.3], respectively). However, in total only 9/22 (41%) in the PZQ arm compared to 6/22 (27%) in the placebo arm reached parasite clearance by D7.

CONCLUSIONS: Findings demonstrate a statistically significant anti-malarial activity of PZQ; however, the observed effect is only moderate compared to current first-line anti-malarial treatments. Future research should investigate the synergistic potential of combining PZQ and antimalarial drugs in malaria and schistosomiasis control.

TRIAL REGISTRATION: The trial was registered in the Pan African Clinical Trials Registry (PACTR); Registration number: PACTR202206584817951; Date of Approval: 10/JUN/2022; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=22586).

PMID:41159886 | DOI:10.1093/infdis/jiaf544

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